COMMISSION REGULATION (EU) 2015/896 of 11 June 2015 amending Annex IV to Regulation (EC) No 396/2005 of the European Parliament and of the Council as

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1 COMMISSION REGULATION (EU) 2015/896 of 11 June 2015 amending Annex IV to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for Trichoderma polysporum strain IMI , Trichoderma asperellum (formerly T. harzianum) strains ICC012, T25 and TV1, Trichoderma atroviride (formerly T. harzianum) strains IMI and T11, Trichoderma harzianum strains T-22 and ITEM 908, Trichoderma gamsii (formerly T. viride) strain ICC080, Trichoderma asperellum (strain T34), Trichoderma atroviride strain I-1237, geraniol, thymol, sucrose, ferric sulphate (iron (III) sulphate), ferrous sulphate (iron (II) sulphate) and folic acid in or on certain products 1

2 2 KOMMISJONSFORORDNING (EU) 2015/896 av 11. juni 2015 om endring av vedlegg IV til europaparlaments- og rådsforordning (EF) nr. 396/2005 med hensyn til grenseverdier for rester av Trichoderma polysporum stamme IMI , Trichoderma asperellum (tidligere T. harzianum) stamme ICC012, T25 og TV1, Trichoderma atroviride (tidligere T. harzianum) stamme IMI og T11, Trichoderma harzianum stamme T-22 og ITEM 908, Trichoderma gamsii (tidligere T. viride) stamme ICC080, Trichoderma asperellum (stamme T34), Trichoderma atroviride stamme I-1237, geraniol, tymol, sukrose, jernsulfat (jern(iii)sulfat), jernsulfat (jern(ii)sulfat) og folinsyre i eller på visse produkter EUROPAKOMMISJONEN HAR under henvisning til traktaten om Den europeiske unions virkemåte, under henvisning til europaparlaments- og rådsforordning (EF) nr. 396/2005 av 23. februar 2005 om grenseverdier for rester av plantevernmidler i eller på næringsmidler og fôrvarer av vegetabilsk og animalsk opprinnelse, og om endring av rådsdirektiv 91/414/EØF( 1 ), særlig artikkel 5 nr. 1, og ut fra følgende betraktninger: 1) Når det gjelder Trichoderma polysporum stamme IMI , Trichoderma asperellum (tidligere T. harzianum) stamme ICC012, T25 og TV1, Trichoderma atroviride (tidligere T. harzianum) stamme IMI og T11, Trichoderma harzianum stamme T-22 og ITEM 908, Trichoderma gamsii (tidligere T. viride) stamme ICC080, Trichoderma asperellum (stamme T34), Trichoderma atroviride stamme I-1237, sukrose, geraniol og tymol, er det ikke fastsatt særlige grenseverdier, og stoffene er heller ikke oppført i vedlegg IV til forordning (EF) nr. 396/2005, og derfor har standardverdien på 0,01 mg/kg fastsatt i artikkel 18 nr. 1 bokstav b) anvendelse. Jernsulfat (jern(iii)sulfat), jernsulfat (jern(ii)sulfat) og folinsyre er oppført i vedlegg IV til forordning (EF) nr. 396/ ) Når det gjelder Trichoderma polysporum stamme IMI ( 2 ), Trichoderma asperellum (tidligere T. harzianum) stamme ICC012, T25 og TV1( 3 ), Trichoderma atroviride (tidligere T. harzianum) stamme IMI og T11( 4 ), Trichoderma harzianum stamme T-22 og ITEM 908( 5 ), Trichoderma gamsii (tidligere T. viride) stamme ICC080( 6 ), Trichoderma asperellum (stamme T34)( 7 ) og Trichoderma atroviride stamme I-1237( 8 ), kunne ikke Den europeiske myndighet for næringsmiddeltrygghet («Myndigheten») fastslå risikoen for forbrukerne ved inntak ettersom noen opplysninger manglet, og de som er ansvarlige for risikohåndteringen, må vurdere spørsmålet ytterligere. De ytterligere vurderingene er gjengitt i de respektive vurderingsrapportene(9), som konkluderte med at stoffene ikke er sykdomsframkallende for mennesker og ikke forventes å produsere toksiner som er av betydning for menneskers helse. I lys av dette mener Kommisjonen at stoffene bør oppføres i vedlegg IV til forordning (EF) nr. 396/ ) Når det gjelder tymol( 10 ), kunne ikke Myndigheten fastslå risikoen for forbrukerne ved inntak ettersom noen opplysninger manglet, og stoffet ble godkjent i samsvar med Kommisjonens gjennomføringsforordning (EU) nr. 568/2013( 11 ) under forutsetning av at det framlegges bekreftende opplysninger. Tymol forekommer naturlig i planter. I lys av dette bør stoffet midlertidig oppføres i vedlegg IV til forordning (EF) nr. 396/2005 i påvente av Myndighetens grunngitte uttalelse i samsvar med artikkel 12 nr. 1. 4) Når det gjelder geraniol( 12 ), kunne ikke Myndigheten fastslå risikoen for forbrukerne ved inntak ettersom noen opplysninger manglet, og stoffet ble godkjent i samsvar med Kommisjonens gjennomføringsforordning (EU) nr. 570/2013( 13 ) under forutsetning av at det framlegges bekreftende opplysninger. Geraniol forekommer naturlig i planter. I lys av dette bør stoffet midlertidig oppføres i vedlegg IV til forordning (EF) nr. 396/2005 i påvente av Myndighetens grunngitte uttalelse i samsvar med artikkel 12 nr. 1. 5) Sukrose er godkjent som basisstoff i samsvar med europaparlaments- og rådsforordning (EF) nr. 1107/2009( 14 ). I lys av Kommisjonens gjennomføringsforordning (EU) nr. 916/2014( 15 ) mener Kommisjonen at stoffet bør oppføres i vedlegg IV til forordning (EF) nr. 396/ ) Jernsulfat (jern(iii)sulfat) er ikke et aktivt stoff i henhold til forordning (EF) nr. 1107/2009. Stoffet omfattes derfor ikke av forordning (EF) nr. 396/2005. I lys av dette bør stoffet slettes fra vedlegg IV til forordning (EF) nr. 396/ ) Ved kommisjonsvedtak 2007/442/EF( 16 ) er det fastsatt at folinsyre ikke skal oppføres i vedlegg I til rådsdirektiv

3 3 91/414/EØF( 17 ). Ettersom artikkel 12 i forordning (EF) nr. 396/2005 derfor ikke får anvendelse på folinsyre, bør fotnote 1 som er oppført etter posten for folinsyre, og som viser til denne bestemmelsen, utgå. 8) Jernsulfat (jern(ii)sulfat) og folinsyre er kosttilskudd i henhold til europaparlaments- og rådsdirektiv 2002/46/EF( 18 ). Andre stoffer oppført i vedlegg IV er kosttilskudd eller aromastoffer. I lys av dette bør ordlyden i fotnote 2 endres, slik at den viser mer generelt til annet særskilt regelverk om næringsmidler og fôrvarer. 9) På grunnlag av Myndighetens konklusjon og de faktorer som er relevante for saken, oppfyller de aktuelle endringene av grenseverdiene de relevante kravene i artikkel 5 nr. 1 og artikkel 14 nr. 2 i forordning (EF) nr. 396/ ) Forordning (EF) nr. 396/2005 bør derfor endres. 11) Tiltakene fastsatt i denne forordning er i samsvar med uttalelse fra Den faste komité for planter, dyr, næringsmidler og fôr VEDTATT DENNE FORORDNING: Artikkel 1 Vedlegg IV til forordning (EF) nr. 396/2005 endres i samsvar med vedlegget til denne forordning. Artikkel 2 Denne forordning trer i kraft den 20. dag etter at den er kunngjort i Den europeiske unions tidende. Denne forordning er bindende i alle deler og kommer direkte til anvendelse i alle medlemsstater. Utferdiget i Brussel, 11. juni For Kommisjonen Jean-Claude JUNCKER President ( 1 ) EUT L 70 av , s. 1. ( 2 ) European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance Trichoderma polysporum strain IMI EFSA Journal 2013;11(1):3035. (38 pp.) doi: /j.efsa ( 3 ) European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance Trichoderma asperellum strains ICC012, T25 and TV1. EFSA Journal 2013;11(1):3036. (61 pp.) doi: /j.efsa ( 4 ) European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance Trichoderma atroviride strains IMI and T11. EFSA Journal 2013;11(1):3056. (59 pp.) doi: /j.efsa ( 5 ) European Food Safety Authority, Conclusion on the peer review of the pesticide risk assessment of the active substance Trichoderma harzianum Rifai strains T-22 and ITEM-908. EFSA Journal 2013;11(10):3055, (47 pp.), doi: /j.efsa ( 6 ) European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance Trichoderma gamsii ICC080. EFSA Journal 2013;11(1):3062. (29 pp.) doi: /j.efsa ( 7 ) European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance Trichoderma asperellum strain T34. EFSA Journal 2012;10(5):2666. (37 pp.) doi: /j.efsa ( 8 ) European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance (Trichoderma atroviride strain I-1237). EFSA Journal 2012;10(10):2706. (33 pp.) doi: /j.efsa

4 4 ( 9 ) Review report for the active substance Trichoderma polysporum IMI Finalised in the Standing Committee on the Food Chain and Animal Health at its meeting on 11 July 2008 in view of the inclusion of Trichoderma polysporum IMI in Annex I of Directive 91/414/EEC. SANCO/1867/08 rev. 6, 11 July Review report for the active substance Trichoderma asperellum (formerly T. harzianum) ICC012. Finalised in the Standing Committee on the Food Chain and Animal Health at its meeting on 11 July 2008 in view of the inclusion of Trichoderma asperellum (formerly T. harzianum) ICC012 in Annex I of Directive 91/414/EEC. SANCO/1842/08 rev. 5, 11 July Review report for the active substances Trichoderma gamsii ICC080 (formerly Trichoderma viride strain ICC080), Trichoderma asperellum T25* (formerly identified as Trichoderma viride strain T-25) and Trichoderma asperellum TV1 (formerly identified as Trichoderma viride strain TV1). Finalised in the Standing Committee on the Food Chain and Animal Health at its meeting on 11 July 2008 in view of the inclusion of Trichoderma gamsii ICC080 (formerly Trichoderma viride strain ICC080), Trichoderma asperellum T25* (formerly identified as Trichoderma viride strain T-25) and Trichoderma asperellum TV1 (formerly identified as Trichoderma viride strain TV1) in Annex I of Directive 91/414/EEC. SANCO/1868/08 rev. 6, 11 July 2014 Review report for the active substance Trichoderma atroviride IMI (formerly T. harzianum IMI ). Finalised in the Standing Committee on the Food Chain and Animal Health at its meeting on 11 July 2008 in view of the inclusion of Trichoderma atroviride IMI (formerly T. harzianum IMI ) in Annex I of Directive 91/414/EEC. SANCO/1866/08 rev. 6, 11 July Review report for the active substance Trichoderma atroviride (formerly T. harzianum) T-11. Finalised in the Standing Committee on the Food Chain and Animal Health at its meeting on 11 July 2008 in view of the inclusion of Trichoderma atroviride (formerly T. harzianum) T-11 in Annex I of Directive 91/414/EEC. SANCO/1841/08 rev. 6, 11 July 2014 Review report for the active substance Trichoderma harzianum T-22. Finalised in the Standing Committee on the Food Chain and Animal Health at its meeting on 11 July 2008 in view of the inclusion of Trichoderma harzianum T-22 in Annex I of Directive 91/414/EEC. SANCO/1839/08 rev. 5, 11 July Review report for the active substance Trichoderma harzianum ITEM 908. Finalised in the Standing Committee on the Food Chain and Animal Health at its meeting on 11 July 2008 in view of the inclusion of Trichoderma harzianum ITEM 908 in Annex I of Directive 91/414/EEC. SANCO/1840/08 rev. 6, 11 July Review report for the active substance Trichoderma asperellum T34. Finalised in the Standing Committee on the Food Chain and Animal Health at its meeting on 20 November 2012 in view of the inclusion of Trichoderma asperellum T34 in Annex I of Directive 91/414/EEC. SANCO/12614/2012 rev. 4, 20 November Review report for the active substance Trichoderma atroviride strain I Finalised in the Standing Committee on the Food Chain and Animal Health at its meeting on 20 November 2012 in view of the inclusion of Trichoderma atroviride strain I-1237 in Annex I of Directive 91/414/EEC. SANCO/12620/2012 rev. 4, 20 November ( 10 ) European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance thymol. EFSA Journal 2012;10(11):2916. (43 pp.) doi: /j.efsa ( 11 ) Kommisjonens gjennomføringsforordning (EU) nr. 568/2013 av 18. juni 2013 om godkjenning av det aktive stoffet tymol i samsvar med europaparlaments- og rådsforordning (EF) nr. 1107/2009 om omsetning av plantevernmidler, og om endring av vedlegget til Kommisjonens gjennomføringsforordning (EU) nr. 540/2011 (EUT L 167 av , s. 33). ( 12 ) European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance geraniol. EFSA Journal 2012;10(11):2915. (44 pp.) doi: /j.efsa ( 13 ) Kommisjonens gjennomføringsforordning (EU) nr. 570/2013 av 17. juni 2013 om godkjenning av det aktive stoffet geraniol i samsvar med europaparlaments- og rådsforordning (EF) nr. 1107/2009 om omsetning av plantevernmidler, og om endring av vedlegget til gjennomføringsforordning (EU) nr. 540/2011 (EUT L 168 av , s. 18). ( 14 ) Europaparlaments- og rådsforordning (EF) nr. 1107/2009 av 21. oktober 2009 om omsetning av plantevernmidler og om

5 5 oppheving av rådsdirektiv 79/117/EØF og 91/414/EØF (EUT L 309 av , s. 1). ( 15 ) Kommisjonens gjennomføringsforordning (EU) nr. 916/2014 av 22. august 2014 om godkjenning av basisstoffet sukrose i samsvar med europaparlaments- og rådsforordning (EF) nr. 1107/2009 om omsetning av plantevernmidler, og om endring av vedlegget til Kommisjonens gjennomføringsforordning (EU) nr. 540/2011 (EUT L 251 av , s. 16). ( 16 ) Kommisjonsvedtak 2007/442/EF av 21. juni 2007 om at visse aktive stoffer ikke skal oppføres i vedlegg I til rådsdirektiv 91/414/EØF, og om tilbakekalling av godkjenninger for plantevernmidler som inneholder nevnte stoffer (EUT L 166 av , s. 16) ( 17 ) Rådsdirektiv 91/414/EØF av 15. juli 1991 om markedsføring av plantefarmasøytiske produkter (EFT L 230 av , s. 1). ( 18 ) Europaparlaments- og rådsdirektiv 2002/46/EF av 10. juni 2002 om tilnærming av medlemsstatenes lovgivning om kosttilskudd (EFT L 183 av , s. 51).

6 6 VEDLEGG I vedlegg IV til forordning (EF) nr. 396/2005 gjøres følgende endringer: 1) Fotnote 2 skal lyde: «2 ) Stoffer oppført i vedlegg IV uten at det påvirker annet særlig regelverk om næringsmidler og fôrvarer, kosttilskudd, aromastoffer osv.». 2) Postene «Trichoderma polysporum stamme IMI », «Trichoderma asperellum (tidligere T. harzianum) stamme ICC012, T25 og TV1», «Trichoderma atroviride (tidligere T. harzianum) stamme IMI og T11», «Trichoderma harzianum stamme T-22 og ITEM 908», «Trichoderma gamsii (tidligere T. viride) stamme ICC080», «Trichoderma asperellum (stamme T34)», «Trichoderma atroviride stamme I- 1237», «sukrose», «geraniol( 1 )( 2 )» og «tymol( 1 )( 2 )» settes inn i alfabetisk rekkefølge. 3) Posten «Jernsulfat (jern(iii)sulfat)» utgår. 4) Henvisningen til fotnote 1 bak posten «Folinsyre» erstattes av en henvisning til fotnote 2. 5) En henvisning til fotnote 2 bak posten «Jernsulfat (jern(ii)sulfat)» tilføyes.

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